aprocitentan

Trade name: TRYVIOTM

Small moleculeapproved

Approved

Mar 19, 2024

An era is a span of time defined for the purposes of chronology or historiography, as in the regnal eras in the history of a given monarchy, a calendar era used for a given calendar, or the geological eras defined for the history of Earth. — Wikipedia

Clinical trial activity

13 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
10
Phase 2
3
Phase 3
2
Phase 4
0

Earliest trial started Jan 25, 2016 (NCT02603809)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Idorsia Pharmaceuticals Ltd. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Mar 19, 2024

    Idorsia Pharmaceuticals Ltd. — Earliest FDA Approval

  2. Mar 19, 2024

    Idorsia Pharmaceuticals Ltd. — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedMar 19, 2024

Chemistry & pharmacology

Loading structure…

SMILES

NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Mol. weight
546.2 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in class

Sources

Also known as

  • act-132577
  • act-132577
  • era
  • era

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06799884Phase 1Jan 18, 2025Idorsia Pharmaceuticals Ltd.
NCT05196399Phase 1Feb 2, 2022Idorsia Pharmaceuticals Ltd.
NCT04252495Phase 1Feb 29, 2020Idorsia Pharmaceuticals Ltd.
NCT04281342Phase 1Jan 14, 2020Idorsia Pharmaceuticals Ltd.
NCT04162366Phase 3Dec 11, 2019Idorsia Pharmaceuticals Ltd., Janssen Pharmaceutica NV
NCT03586570Phase 1Jul 17, 2018Idorsia Pharmaceuticals Ltd., Janssen Pharmaceutica NV
NCT03541174Phase 3Jun 18, 2018Idorsia Pharmaceuticals Ltd., Janssen Pharmaceutica NV
NCT03245229Phase 1Aug 10, 2017Idorsia Pharmaceuticals Ltd.
NCT03165071Phase 1Jun 3, 2017Actelion
NCT03100591Phase 1Mar 28, 2017Actelion
NCT02841761Phase 1Jul 1, 2016Actelion
NCT02708004Phase 1Jun 1, 2016Actelion
NCT02603809Phase 2Jan 25, 2016Actelion
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Idorsia Pharmaceuticals Ltd.For profit8822017
ActelionFor profit5522016
Janssen Pharmaceutica NVFor profit3022018
3 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Idorsia Pharmaceuticals Ltd.For profitNDAMar 19, 2024